Managing particulates in cell therapy: Guidance for best practice.
Publication
, Journal Article
Clarke, D; Stanton, J; Powers, D; Karnieli, O; Nahum, S; Abraham, E; Parisse, J-S; Oh, S
Published in: Cytotherapy
September 2016
The intent of this article is to provide guidance and recommendations to cell therapy product sponsors (including developers and manufacturers) and their suppliers in the cell therapy industry regarding particulate source, testing, monitoring and methods for control. This information is intended to help all parties characterize the processes that generate particulates, understand product impact and provide recommendations to control particulates generated during manufacturing of cell therapy products.
Duke Scholars
Published In
Cytotherapy
DOI
EISSN
1477-2566
ISSN
1465-3249
Publication Date
September 2016
Volume
18
Issue
9
Start / End Page
1063 / 1076
Related Subject Headings
- Risk Assessment
- Quality Control
- Patient Safety
- Particulate Matter
- Immunology
- Humans
- Cell- and Tissue-Based Therapy
- Cell Culture Techniques
- 3206 Medical biotechnology
- 3204 Immunology
Citation
APA
Chicago
ICMJE
MLA
NLM
Clarke, D., Stanton, J., Powers, D., Karnieli, O., Nahum, S., Abraham, E., … Oh, S. (2016). Managing particulates in cell therapy: Guidance for best practice. Cytotherapy, 18(9), 1063–1076. https://doi.org/10.1016/j.jcyt.2016.05.011
Clarke, Dominic, Jean Stanton, Donald Powers, Ohad Karnieli, Sagi Nahum, Eytan Abraham, Jean-Sebastien Parisse, and Steve Oh. “Managing particulates in cell therapy: Guidance for best practice.” Cytotherapy 18, no. 9 (September 2016): 1063–76. https://doi.org/10.1016/j.jcyt.2016.05.011.
Clarke D, Stanton J, Powers D, Karnieli O, Nahum S, Abraham E, et al. Managing particulates in cell therapy: Guidance for best practice. Cytotherapy. 2016 Sep;18(9):1063–76.
Clarke, Dominic, et al. “Managing particulates in cell therapy: Guidance for best practice.” Cytotherapy, vol. 18, no. 9, Sept. 2016, pp. 1063–76. Epmc, doi:10.1016/j.jcyt.2016.05.011.
Clarke D, Stanton J, Powers D, Karnieli O, Nahum S, Abraham E, Parisse J-S, Oh S. Managing particulates in cell therapy: Guidance for best practice. Cytotherapy. 2016 Sep;18(9):1063–1076.
Published In
Cytotherapy
DOI
EISSN
1477-2566
ISSN
1465-3249
Publication Date
September 2016
Volume
18
Issue
9
Start / End Page
1063 / 1076
Related Subject Headings
- Risk Assessment
- Quality Control
- Patient Safety
- Particulate Matter
- Immunology
- Humans
- Cell- and Tissue-Based Therapy
- Cell Culture Techniques
- 3206 Medical biotechnology
- 3204 Immunology